Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
研究概览
简要总结
Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Low or intermediate risk surgery or noninvasive procedures in the supine position
- •General anaesthesia and volume-controlled mechanical ventilation.
排除标准
- •Non sinus heart rhythm
- •Left Ventricular Ejection Fraction < 50%
- •Documented right ventricle failure
- •Lack of patient consent
- •Pregnancy
- •Minor patient or under tutorship
- •Presence of spontaneous ventilatory movements (attested by a real respiratory rate higher than the set respiratory rate)
- •Report HR / RR <3.6 (HR: heart rate, RR: respiratory rate)
- •Open chest surgery
- •Laparoscopic surgery
- •Vital or lateral decubitus surgery
结局指标
主要结局
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
时间窗: 30 minutes
Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements
次要结局
未报告次要终点
